FDA 510(k)

RhythmStar 系统

K号: K233584 · 2024-07-08

决定日期2024-07-08

产品代码QYX

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

RhythmStar System is the device name listed in this FDA 510(k) record. The listed applicant is RhythMedix, LLC. It received FDA 510(k) clearance on 2024-07-08 under 510(k) number K233584. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RhythmStar System?

RhythmStar System is a medical device that received FDA 510(k) clearance on 2024-07-08. The listed applicant is RhythMedix, LLC. The 510(k) number is K233584.

When did RhythmStar System receive FDA 510(k) clearance?

RhythmStar System received FDA 510(k) clearance on 2024-07-08, under 510(k) number K233584.

Who is the listed applicant for RhythmStar System?

The FDA 510(k) record lists RhythMedix, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RhythmStar System?

The FDA product code for RhythmStar System is QYX.

列明RhythMedix, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250793RhythmStar 系统 (SL)

官方来源

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